Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, "Luigi Sacco" University Hospital, Università di Milano, Milan, Italy.
Department of Biomedical and Clinical Sciences, Department of Psychiatry, ASST Fatebenefratelli-Sacco, University of Milan, Milan, Italy.
Expert Rev Clin Pharmacol. 2023 May;16(5):453-465. doi: 10.1080/17512433.2023.2211261. Epub 2023 May 15.
Immunoassay urine drug screen (UDS) is frequently used in clinical practice for initial screening process, being generally available, fast, and inexpensive. Exposure to widely prescribed drugs might determine false-positive UDS amphetamines, leading to diagnostic issues, wrong therapeutic choices, impairment of physician-patient relationship, and legal implications.
To summarize and comment on a comprehensive list of compounds responsible for UDS false positives for amphetamines, we conducted a literature review on PubMed along with a comparison with Real-World Data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database analysis between 2010 and 2022. Forty-four articles and 125 Individual Case Safety Reports (ICSR) involving false-positive amphetamine UDS in psychiatric patients were retrieved from FAERS.
False-positive results were described in literature for antidepressants, atomoxetine, methylphenidate, and antipsychotics, but also for non-psychiatric drugs of common use, such as labetalol, fenofibrate, and metformin. Immunoassay method is usually responsible for false-positive results, and in most cases, mass spectrometry (MS) does not eventually confirm the UDS positivity. Physicians should be aware of immunoassays' limitations and when turning to a confirmatory test. Any new cross-reaction should be reported to pharmacovigilance activities.
免疫分析法尿液药物检测(UDS)常用于临床初步筛选,具有普遍适用性、快速和廉价的特点。广泛使用的药物可能导致 UDS 检测出安非他命假阳性,从而导致诊断问题、错误的治疗选择、医患关系受损和法律问题。
为了总结和评论导致 UDS 安非他命假阳性的一系列化合物,我们在 PubMed 上进行了文献回顾,并对 2010 年至 2022 年期间食品和药物管理局不良事件报告系统(FAERS)数据库分析的真实世界数据进行了比较。从 FAERS 中检索到 44 篇文章和 125 份涉及精神病患者安非他命 UDS 假阳性的个别病例安全报告(ICSR)。
文献中描述了抗抑郁药、阿托莫西汀、哌甲酯和抗精神病药会导致假阳性结果,但也有一些常见的非精神科药物会导致假阳性,如拉贝洛尔、非诺贝特和二甲双胍。免疫分析法通常是假阳性结果的原因,在大多数情况下,质谱(MS)最终并未确认 UDS 阳性。医生应了解免疫分析的局限性,并在需要时进行确认性检测。任何新的交叉反应都应报告给药物警戒活动。